A randomized, double-blinded, placebo-controlled, single-centre, clinical safety and efficacy study in subjects with overweight or Obese Class - I, to evaluate the degree of significant weight loss by regular intake of Phaseolean (White Kidney Bean Standardized Extract). This study is dose-response study to evaluate effectiveness of two different dosage i.e. 1500 mg Versus 3000 mg. 22 subjects will be enrolled per test treatment to complete 20 subjects per test treatment.
A randomized, double-blinded, placebo-controlled, single-centre, clinical safety and efficacy study in subjects with overweight or Obese Class - I, to evaluate the degree of significant weight loss by regular intake of Phaseolean (White Kidney Bean Standardized Extract). This study is dose-response study to evaluate effectiveness of two different dosage i.e. 1500 mg Versus 3000 mg. 22 subjects will be enrolled per test treatment to complete 20 subjects per test treatment. The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits. * Visit 01 (Within 30 Days): Screening, Baseline evaluations * Visit 02 (Day 01): Enrolment \& Treatment phase start * Visit 03 (Day 21): Treatment Period, Evaluations * Visit 04 (Day 45): Treatment Period, Evaluations \& End of Study Visit * Telephonic follow-up will be taken thrice a week (Monday, Wednesday and Friday) during an entire study to check compliance with the diet plan and study treatment. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be telephonically contacted by recruiting department prior to the enrolment visit. Subjects will be instructed during screening (prior to enrolment) not to consume any weight-loss medications, or supplementation or topical anti-cellulite treatment during the study. Eligible subjects will be randomly assigned equally to one of three groups in a 1:1:1 ratio as follows: * Arm A (Treatment A): Subjects will be given a test treatment of 1500 mg/day (2 capsules in the morning before breakfast, 2 capsules in the afternoon before lunch and 2 capsules at night before dinner; each capsule containing 250 mg Phaseolean (White Kidney Bean Standardized Extract) along with the diet regimen and exercise as advised by the clinical nutritionist /Dietician (Diet of 2000 kcal/day throughout the study and walking exercise for 45 mins daily for consecutive 45 Days). * Arm B (Treatment B): Subjects will be given a test treatment of 3000 mg/day (2 capsules in the morning before breakfast, 2 capsules in the afternoon before lunch and 2 capsules at night before dinner; each capsule containing 500 mg Phaseolean (White Kidney Bean Standardized Extract) along with the diet regimen and exercise as advised by the clinical nutritionist /Dietician (Diet of 2000 kcal/day throughout the study and walking exercise for 45 mins daily for consecutive 45 Days). * Arm C (Treatment C): Subjects will be given placebo capsules (2 capsules in the morning before breakfast, 2 capsules in the afternoon before lunch and 2 capsules at night before dinner; each capsule containing 250 mg Resistant Dextrin as Placebo along with the diet regimen and exercise as advised by the clinical nutritionist /Dietician (Diet of 2000 kcal/day throughout the study and walking exercise for 45 mins daily for consecutive 45 Days). Subjects will be followed up as per the schedule of assessments. Assessment of efficacy parameters will be done before test treatment usage on Day 1, and will be compared with after test treatments usage on Day 21 (+2 Days), \& Day 45 (+2 Days) within treatments and between treatments as listed below. * Anthropometry: Height, Weight, Body Mass Index (BMI), Hip and Waist Circumference * Skinfold fat thickness * Maximum Oxygen consumption (VO2) * Vitals (Heart Rate, Blood Pressure) * ECG and Chest X-Ray * Blood Biochemical Parameters (Serum albumin, total protein, AST, ALT, glucose, BUN, uric acid, creatinine levels, Random Insulin) * Biomarkers - Amylase, Lipid Profile, HbA1c * Hedonic Questionnaires - about product perception and consumer feedback (Weight reduction, feeling of the light weight of the body, reduction of Hip and Waist circumference, reduction in skinfold fat thickness, hunger feeling, satiety level etc.) * Digital Photographs: Body photographs with measurement of waist and hip circumference - before test treatment usage and after test treatment usage
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
66
Mode of Usage: 2 capsules each time before 3 daily meals for consecutive 45 days. Route of Administration: Oral Administration with a glassful (approx. 250 mL) of water.
Mode of Usage: 2 capsules each time before 3 daily meals for consecutive 45 days. Route of Administration: Oral Administration with a glassful (approx. 250 mL) of water.
Resistant dextrin is a soluble fiber, derived from wheat or corn starch and is prepared by highly controlled partial hydrolysis and repolymerization of the dextrinization process
NovoBliss Research Pvt Ltd
Ahmedabad, Gujarat, India
Change in Weight (Unit: Kg)
Mean percentage change in Body Weight in the overweight and Obese Class - I population (Males and Females) between the treatment and placebo group
Time frame: Day 1 (inclusion) to 45 Days
Change in BMI (Unit: Kg/m2)
Mean percentage change in BMI in the overweight and Obese Class - I population (Males and Females) between the treatment and placebo group
Time frame: Day 1 (inclusion) to 45 Days
Percentage of subjects loosing weight
To evaluate the effectiveness of the test treatment in terms of percentage of subjects loosing weight between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Change in Hip, Waist, and Thigh Circumference
To evaluate the effectiveness of the test treatment for change in Hip, waist, and thigh circumference between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Change in total Body fat
To evaluate the effectiveness of the test treatment for change in total body fat by measuring skinfold fat thickness between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Change in random blood sugar
To evaluate the effectiveness of the test treatment for change in random blood sugar between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Change in HbA1C
To evaluate the effectiveness of the test treatment for change in HbA1C between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 45
Change in Lipoprotein lipids (HDL, LDL, Triglyceride, and Cholesterol)
To evaluate the effectiveness of the test treatment for change in Lipoprotein Lipids (HDL, LDL, Triglyceride, and Cholesterol) between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 45
Change in Serum Creatinine
To evaluate the effectiveness of the test treatment for change in Serum Creatinine between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 45
Change in Serum Amylase
To evaluate the effectiveness of the test treatment for change in Serum Amylase between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 45
Change in AST and ALT levels
To evaluate the effectiveness of the test treatment for change in AST and ALT levels between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 45
Change in blood biochemical parameters (Serum Albumin, Total Protein, Blood Urea Nitrogen (BUN), Uric Acid, Random Insulin
To evaluate the effectiveness of the test treatment for change in blood biochemical parameters (Serum Albumin, Total Protein, Blood Urea Nitrogen (BUN), Uric Acid, Random Insulin between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 45
Improvement in Maximum Oxygen Consumption (VO2)
To evaluate the effectiveness of the test treatment for improvement in Maximum Oxygen Consumption between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 45
Change in BMI
To evaluate the effectiveness of the test treatment for change in BMI between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Change in Heart rate
To evaluate the effectiveness of the test treatment for change in Heart rate between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Change in Electrocardiogram (P wave, QRS interval, QT interval, PR interval)
To evaluate the effectiveness of the test treatment for change in Electrocardiogram (P wave, QRS interval, QT interval, PR interval) between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 45
Change in Blood Pressure (Both)
To evaluate the effectiveness of the test treatment for change in Blood Pressure (Both) between the treatment and placebo group
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
Test treatment perception and consumer feedback on weight reduction, feeling of the light weight of the body, reduction of hip and waist circumference, reduction in skinfold fat thickness, hunger feeling, satiety level.
To evaluate the Effect of test treatment in terms of product perception and consumer feedback weight reduction, feeling of the light weight of the body, reduction of hip and waist circumference, reduction in skinfold fat thickness, hunger feeling, satiety level - using hedonic questionnaires
Time frame: From baseline (i.e. Day 1) to Day 21, Day 45
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